Cleared Traditional

K070801 - IMM HYPODERMIC NEEDLE SET

K070801 is an FDA 510(k) clearance for IMM HYPODERMIC NEEDLE SET, manufactured by Innovative Medical Manufacturing Co.. The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K070801 · Innovative Medical Manufacturing Co. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2007
Decision
62d
Days
Class 2
Risk

K070801 is an FDA 510(k) clearance for the IMM HYPODERMIC NEEDLE SET. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Innovative Medical Manufacturing Co. (Houston, US). The FDA issued a Cleared decision on May 24, 2007 after a review of 62 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5440 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Innovative Medical Manufacturing Co. devices

FDA 510(k) Submission Details - K070801

510(k) Number K070801 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 23, 2007
Decision Date May 24, 2007
Days to Decision 62 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
67d faster than avg
Panel avg: 129d · This submission: 62d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FPA Device Classification - Class 2, Special Controls

Product Code FPA Set, Administration, Intravascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5440
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - FPA Set, Administration, Intravascular

All 588
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K070801.
SURFLO WINGED INFUSION SET WITH NEEDLE PROTECTION (SURSHIELD)
K072894 · Terumo Europe N.V. · Nov 2007
MODIFICATION TO EZ HUBER SAFETY INFUSION SET
K071846 · Pfm Medical, Inc. · Aug 2007
SURFLO WINGED INFUSION SET WITH FILTER AND NEEDLE PROTECTION (SURSHIELD)
K070547 · Terumo Europe N.V. · May 2007
SURFLO WINGED INFUSION SET
K070362 · Terumo Europe N.V. · May 2007
SPIROS
K070532 · Icu Medical, Inc. · Mar 2007
EZ-CONNECT
K061771 · Vidacare Corporation · Jul 2006